BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1674442 · Received May 4, 2010

    Report

    Report Number
    2124215-2010-09881
    Event Type
    Death
    Date Received
    May 4, 2010
    Date of Event
    August 10, 2009
    Report Date
    April 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D WILL NOT BE RETURNED TO BSC FOR LAB ANALYSIS BECAUSE THE DEVICE WAS NOT EXPLANTED WHEN THIS PT PASSED AWAY. AT THIS TIME, THERE IS NO ADDITIONAL INFO. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE PT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPIRED. THE PT HAD RECEIVED AN EXTERNAL DEFIBRILLATION SHOCK BY THEIR HEALTH CARE PROVIDER (HCP) AFTER A MISDIAGNOSIS OF VENTRICULAR TACHYCARDIA (VT). FURTHER EVAL OF THE PT'S CONDITION, CONFIRMED AN ENDLESS LOOP TACHYCARDIA (ELT) RATHER THAN TRUE VT. NO ALLEGATION AGAINST THE BSC DEVICE AS A CAUSE OR CONTRIBUTOR IN THE PT'S DEATH. SUBSEQUENTLY, ADDITIONAL INFO WAS RECEIVED THAT ALTHOUGH INITIALLY THERE WAS NO ALLEGATION TOWARDS THE BSC DEVICE, AFTER FURTHER INVESTIGATION, THE PHYSICIAN NOW BELIEVES THIS CRT-D COULD HAVE CONTRIBUTED TO THIS PT'S DEATH. IT IS BELIEVED THAT IF THIS PT WAS NOT IMPLANTED WITH A DEVICE, THIS ELT WOULD NOT HAVE OCCURRED, AS WELL AS THE ALTERATION OF HIS HEMODYNAMIC STATUS FOLLOWING THE EXTERNAL SHOCK, WHICH LEAD TO THIS PT'S DEATH. IT WAS NOTED, THERE WAS NO DIRECT ALLEGATION FROM THE PHYSICIAN BECAUSE THE DEVICE FUNCTIONED AS DESIGNED, BUT THIS WAS SEEN AS A LIMIT BY THE PHYSICIAN WITH REGARDS TO THE DEVICE NOT BEING ABLE TO DETECT AND CONVERT AN ELT WHEN THE ELT IS LESS THAN THE MAX/UPPER RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Death